Circulating Tumor DNA in Patients at High Risk for Lung Cancer

Terminated

• Conditions: Cancer of the Lung; Adenocarcinoma of the Lung; Lung Cancer; Lung Neoplasms; Non Small Cell Carcinoma of the Lung; Small Cell Carcinoma of the Lung

• Registration Number: NCT02715102
• Lead Sponsor: Pathway Genomics

Brief Summary

Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the utility of molecular diagnostic assays for the early detection of lung cancer.

Detailed Description

Specific somatic (i.e. acquired and not inherited) mutations have been found in many cancers. Some of these cancers shed this DNA into the patient's blood stream and is called circulating tumor DNA (ctDNA). Pathway Genomics has developed a new molecular assay that uses blood plasma as the source of DNA fragments. The ctDNA is isolated, amplified and analyzed for the presence of one or more of 96 known mutations that are found in 9 cancer driver genes. This technique of using a "liquid biopsy" to screen for and monitor cancer has been documented in a number of recent medical publications. However, the majority of published studies are on subjects who have already been diagnosed with cancer. Therefore, the investigators wish to look at a population of patients who are scheduled to undergo a diagnostic or therapeutic bronchoscopy or thoracotomy without a know history of cancer (other than basal cell carcinomas of the skin). The blood will be drawn at the time of or a few weeks before the procedure. The analysis of the blood sample will take placed in the Pathway Genomics clinical laboratory which is Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified.

Following an informed consent process, the patients will fill out a health questionnaire and will have the blood drawn prior to the surgical procedure. Up to 30 ml of blood (approximately 2 tablespoons) will be drawn at any one time. The patient will be asked to agree to being contacted by the investigators yearly for up to 5 years to provide follow-up medical information. No patient will be identified in presentations or publications resulting from this work and all data will be reported from analysis of combined information from participants in this study.

Individuals may participate in this study if they are 18 years of age or older, have not had a prior diagnosis of cancer (other than a skin cancer or if they are undergoing the thoracic surgical procedure for a cancer that was diagnosed within the prior month), and are undergoing a diagnostic or therapeutic bronchoscopy or thoracotomy.

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Study Start: 2016-06
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• 18 years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed).

Exclusion Criteria

• Prior history of cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with lung cancer who had a positive ctDNA result (true positive)	5 years	ctDNA results will be correlated with pathology and subsequent clinical findings.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients without lung cancer who had a negative ctDNA result (true negative)	5 years	ctDNA results will be correlated with pathology and subsequent clinical findings.
Percentage of patients with lung cancer who had a negative ctDNA result (false negative)	5 years	ctDNA results will be correlated with pathology and subsequent clinical findings.
Percentage of patients who develop any cancer during the 5 years of follow-up	5 years	ctDNA results will be correlated with pathology and subsequent clinical findings.
Percentage of patients without lung cancer who had a positive ctDNA result (false positive)	5 years	ctDNA results will be correlated with pathology and subsequent clinical findings.

Trial Locations

Locations (1)

Cardiothoracic Outpatient Clinic, Providence Saint John's Health Center, 2121 Santa Monica Blvd.; 🇺🇸 Santa Monica, California, United States